26 April 2012
The Medicines and Healthcare products Regulatory Agency
(MHRA) have issued a further medical device alert
in relation to leads manufactured by St Jude Medical. The alert was prompted by reported defects with the Bipolar QuickSite and QuickFlex lead models: 1056T, 1058T, 1156t and 1158T, causing risk of “worsening heart failure symptoms due to wear and / or abrasion of lead insulation after implantation”.
The MHRA alert follows on from a field safety notice issued by St Jude Medical on 3 April 2012 to physicians, about a “possible safety problem with some of its QuickSite and QuickFlex left-ventricular bipolar cardiac resynchronization therapy (CRT) leads”. The notice was said to be restricted to those leads that use silicone insulation in the distal portion of the lead. St Jude Medical was stated to be immediately discontinuing sales of the recalled models as a “conservative measure”.
The defect with the lead is said to be caused by abrasion of the silicone insulation in the distal portion of the lead, allowing the cable conductors to exit the lead body. St Jude Medical admitted in their Field Safety Notice that “based on the existing data, the exact rate of externalised cables is unknown”. It has been estimated that there are approximately 101,000 affected leads in service worldwide.
This device alert follows the much publicised recall of the St Jude’s Medical Riata or Riata ST leads, also relating to silicone insulation problems in 2011. Amidst uncertainty relating to the proposed treatment of patients implanted with the affected leads in 2011, Dr Robert Hauser, Abbott Northwestern Hospital, stated that the recall was “a very complex one” with “a lot of variables”. He further emphasised the need for more data to assist with patient management.
The alert offers advice to cardiologists and cardiac physiologists who manage patients implanted with the QuickSite and QuickFlex leads. Practitioners have been told not to implant the affected leads and to arrange systems of early follow up appointments with identified patients.
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